MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Pannus (1447); Corneal Scar (1793); Corneal Ulcer (1796); Dry Eye(s) (1814); Corneal Clouding/Hazing (1878); Keratitis (1944); Neovascularization (1978); Pain (1994); Red Eye(s) (2038); Swelling (2091); Corneal Infiltrates (2231)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019, a patient (pt) reported a corneal infection while wearing acuvue® oasys® brand contact lenses (cl).The pt visited an ophthalmologist (unspecified date) and was treated for a corneal infection on the left eye (os).The pt was prescribed vigamox 6 times a day and instructed to discontinue cl wear until healed.Pt is due to return for follow-up (fu) on (b)(6) 2019.The ophthalmologist told the pt that it is likely that a cl scratched the cornea.The pt reported that the issue started about a month ago.On (b)(6) 2019, additional information was received from the treating ophthalmologist: the pt was diagnosed with a central corneal ulcer os on (b)(6) 2019.The pt was prescribed vigamox 6 times a day until fu visit on (b)(6) 2019.The pt was prescribed prednisolone bid until next fu visit on (b)(6) 2019.The os corneal ulcer is resolving and there does not appear to be any visual acuity changes.On (b)(6) 2019, medical records and pharmacy receipts were received from the pt: date of visit: (b)(6) 2019 (initial emergency visit).Chief complaint: on (b)(6) 2019, the pt¿s os became very red and swollen while wearing cl.The pt stopped wearing the cls and the redness slowly resolved.The pt¿s symptoms cleared up over the past week; however, the distance vision in os has decreased drastically.Pt reported no significant past ocular history.Exams: l&a ¿ lids os: t blepharitis, lul 2+ meibomitis, multiple capped glands in upper lids; anesthetic: fluorescein strips, proparacaine ou.Os slit lamp exam: conjunctiva: clear; cornea: t spk; pannus peripheral superficial vascularization; light central infiltrate with diffused corneal haze; no epi defect; chamber: deep and quiet; iris & pupil: wnl; lens: clear.Os distance vision: cc 20/50-2 ph 20/40+2.Diagnosis, assessment and plan: corneal ulcer os ¿ start vigamox 6x/day os and fu on monday ((b)(6) 2019); corneal pannus os ¿ limit cl wear, discussed cl overwear/hygiene, advised pt to never sleep in cls; blepharitis/meibomitis os upper lid ¿ multiple capped glands in upper lids, hot compresses and lid hygiene discussed; dry eye syndrome k sicca os ¿ artificial tears prn.Date of visit: (b)(6) 2019: chief complaint: fu exam to monitor corneal ulcer os.Pt stated os felt much better and pt has been complaint with eye drops.Exams: l&a ¿ lids os: same as last visit; iop os: tp ¿ 11 12:19pm; anesthetic: fluoracaine os.Os slit lamp exam: t spk; pannus peripheral superficial vascularization; light central infiltrate with diffused corneal haze improving; no epi defect; chamber: deep and quiet; iris & pupil: wnl; lens: clear.Os distance vision: cc 20/25-1 ph 20/25-2.Diagnosis, assessment and plan: corneal ulcer os ¿ reduce vigamox 4x/day os and start prednisone bid os and fu in 1 week; corneal pannus os ¿ limit cl wear, discussed cl overwear/hygiene, advised pt to never sleep in cls; blepharitis/2+ meibomitis os upper lid ¿ multiple capped glands in upper lids, hot compresses and lid hygiene discussed, discussed use of massage mask; dry eye syndrome k sicca os ¿ artificial tears prn.Date of visit: (b)(6) 2019: chief complaint: one-week fu to monitor corneal ulcer os.Pt stated condition has improved significantly and has made about a 90% recovery.Pt no longer feels pain.Exams: l&a ¿ lids os: same as last visit; iop os: tp ¿ 14 12:44pm.Os slit lamp exam: t spk; pannus peripheral superficial vascularization; light punctate central scar, no infiltrate or epi defect; chamber: deep and quiet; iris & pupil: wnl; lens: clear.Distance vision os: cc 20/25-2 ph 20/25- diagnosis, assessment and plan: corneal ulcer os ¿ cl related ulcer, resolved with very small light scar, reduce vigamox 2x/day os and continue prednisone bid os for 1 week then stop all drops; corneal pannus os ¿ limit cl wear, discussed cl overwear/hygiene, advised pt to never sleep in cls; blepharitis/2+ meibomitis os upper lid ¿ multiple capped glands in upper lids; hot compresses and lid hygiene discussed, discussed use of massage mask; dry eye syndrome k sicca os ¿ artificial tears prn; pt interested in lasik; possible lae in future once cu os is fully healed; fu: 2-4 weeks for lasik eval.Pharmacy receipt dated (b)(6) 2019: moxifloxacin 0.5% eye drops ¿ instill 1 drop 6 times daily into os.Pharmacy receipt dated (b)(6) 2019: prednisolone ac 1% eye drops ¿ instill 1 drop into os twice daily.Pharmacy receipt dated (b)(6) 2019: moxifloxacin 0.5% eye drops ¿ instill 1 drop into the os 4 times a day.No additional information has been received.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot b00qtg6 was produced under normal conditions.One lens was received in a lens case.The lens met company standards for base curve, center thickness, and diameter.Visual inspection revealed no visual attributes.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 8449462
• MDR Text Key: 139753458
• Report Number: 1057985-2019-00028
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: PH
• Device Lot Number: B00QTG6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 41 YR